Forceps and collection assembly with accompanying mechanisms and related methods of use

ABSTRACT

An embodiment of the invention includes a method for acquiring a plurality of tissue samples. The method includes using a device to cut a first tissue sample from an internal tissue tract of a patient and storing the first tissue sample in a container. Without removing the device from the patient, the method further includes using the device to cut a second tissue sample from the internal tissue tract and storing the tissues ample in the container. The method also includes coupling a fluid delivery device to the container to flush the first and second tissue samples from the container.

CROSS-REFERENCE TO RELATED APPLICATIONS

This is a divisional of application Ser. No. 10/658,261, filed Sep. 10,2003, the contents of which are relied upon and incorporated herein byreference.

FIELD OF THE INVENTION

The invention relates to a forceps and collection assembly havingaccompanying mechanisms and their related methods of use. Morespecifically, the invention relates to a forceps for obtaining andcollecting multiple samples in a collection assembly, such as a pouch.The accompanying mechanisms include a flush adapter to aid in removal ofsamples from the collection assembly and, when used in a medicalprocedure such as an endoscopic biopsy procedure, a working channel capto aid in insertion and removal of the forceps and collection assemblyfrom an endoscope channel.

BACKGROUND OF THE INVENTION

Irritable bowel disease, Crohn's disease, and Barrett's esophagus arejust some of the gastrointestinal diseases that often require biopsy ortissue samples to be taken from the gastrointestinal tract. Often, alarge number of biopsy samples must be taken from various locations inthe gastrointestinal tract in order to properly diagnose the disease.

Various current biopsy forceps, however, are only designed to take oneor two samples in a single pass. Thus, during some procedures thatroutinely require as many as twenty or more samples, the forceps must beadvanced into and retracted out of the gastrointestinal tract numeroustimes. Such advancing and retracting of the forceps is time consuming,can cause trauma to the surrounding tissue, and can create sterilityissues. Accordingly, a device that minimizes the number of advancementsand retractions of the forceps by acquiring and storing multiple biopsysamples in a single pass is desirable. In addition, once multiplesamples have been obtained, a method and device for sample removal thatovercomes, for example, the tissue sticking to or otherwise being lodgedwithin the device, is needed. Moreover, a device is needed that willinsert into and out of a working channel of an endoscope without losingthe samples or compressing the samples, damaging their integrity andcausing a loss in diagnostic quality.

It is accordingly an object of the invention to have a forceps andcollection assembly that facilitate the collection and storage ofmultiple biopsy samples, and accompanying mechanisms that facilitate theremoval of the biopsy samples from the pouch while allowing them tomaintain their integrity.

SUMMARY OF THE INVENTION

In accordance with the invention, an embodiment of the inventionincludes a device for storing a plurality of tissue samples having anelongate container with a cavity for storing a plurality of tissuesamples, an open top, and an open bottom in flow communication with theopen top. The device also has a cutting portion coupled to the open topand configured to cut the plurality of tissue samples that deposit inthe cavity through the open top. A portion of the elongate containeradjacent the open bottom has a restriction smaller than the open bottomto prevent the plurality of tissue samples from exiting the containervia the open bottom.

According to another aspect of the invention, an embodiment of theinvention includes a device for storing a plurality of tissue sampleshaving an elongate container with a cavity for storing a plurality oftissue samples, an open top, and an open bottom in flow communicationwith the open top. The open top and the open bottom are aligned with alongitudinal axis of the cavity. The device also has a cutting portioncoupled to the open top and configured to cut the plurality of tissuesamples that deposit in the cavity through the open top. A portion ofthe elongate container adjacent to the open bottom is configured toprevent the plurality of tissue samples from exiting the container viathe open bottom.

According to yet another aspect of the invention, an embodiment of theinvention includes an endoscope working channel cap assembly forcoupling to an existing seal. The cap assembly includes an interfaceconfigured to be coupled to a proximal end of a working channel of anendoscope, an introducer extending from the interface and configured tobe advanced through the existing seal and hold open the existing seal,and a seal portion connected to the interface. The seal portion includesa seal disposed therein and configured to prevent flow communicationacross the seal.

According to still another aspect of the invention, an embodiment of theinvention includes a flushing device having an elongate member defininga receiving cavity, an open top, and an open bottom. The flushing devicealso includes a connector proximate the open bottom and configured toprovide a fluid tight connection with a source of fluid, and a nozzlewithin the elongate member between the open bottom and the receivingcavity. The open bottom is in flow communication with the open top viathe nozzle and the receiving cavity.

According to a further aspect of the invention, an embodiment of theinvention includes an endoscopic instrument having a proximal handlecoupled to a distal end effector assembly via an elongate member. Thedistal end effector assembly includes an upper jaw, a lower jawrotatable relative to the upper jaw, and a collection device coupled tothe lower jaw. The collection device includes an elongate containerhaving a cavity for storing a plurality of tissue samples, an open top,and an open bottom in flow communication with the open top. The upperjaw and the lower jaw are configured to cut the plurality of tissuesamples that deposit in the cavity through the open top, and a portionof the elongate container adjacent the open bottom has a restrictionsmaller than the open bottom to prevent the plurality of tissue samplesfrom exiting the container via the open bottom.

According to a still further aspect of the invention, an embodiment ofthe invention includes a method of acquiring a plurality of tissuesamples. The method includes using a device to cut a first tissue samplefrom an internal tissue tract of a patient and storing the first tissuesample in a container disposed within the internal tissue tract. Themethod also includes using the device to cut at least one additionaltissue sample from the internal tissue tract without removing the devicefrom the patient. The method further includes storing the at least oneadditional tissue sample in the container disposed within the internaltissue tract. The container has a cavity for storing the first and atleast one additional tissue sample, an open top, and an open cavity inflow communication with the open top. A portion of the containeradjacent the open bottom has a restriction smaller than the open bottomto prevent the first and additional multiple tissue samples from exitingthe container via the open bottom.

According to a yet further aspect of the invention, an embodiment of theinvention includes a method of removing tissue samples from a container.The method includes providing a container having a cavity with tissuesamples, an open top, and an open bottom in flow communication with theopen top. A portion of the container adjacent the open bottom has arestriction smaller than the open bottom to prevent the tissue samplesfrom exiting the container via the open bottom. The method also includesdelivering fluid through the open bottom to flush the tissue samples outof the cavity via the open top.

Additional objects and advantages of the invention will be set forth inpart in the description which follows, and in part will be obvious fromthe description, or may be learned by practice of the invention. Theobjects and advantages of the invention will be realized and attained bymeans of the elements and combinations particularly pointed out in theappended claims.

The foregoing general description and the following detailed descriptionare exemplary and explanatory only and are not restrictive of theinvention, as claimed.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated in and constitute apart of this specification, illustrate embodiments of the invention andtogether with the description, serve to explain the principles of theinvention.

FIG. 1 is a perspective view of a forceps and collection assemblyaccording to an embodiment of the present invention.

FIG. 2A is a perspective view of an upper jaw of the forceps andcollection assembly of FIG. 1.

FIG. 2B is a perspective view of a lower jaw of the forceps andcollection assembly of FIG. 1.

FIG. 3 is a schematic view of a collection assembly and lower jaw of theforceps and collection assembly of FIG. 1.

FIG. 4 is a schematic cross-sectional view of an endoscope workingchannel cap assembly for use with the forceps and collection assembly ofFIG. 1 according to an embodiment of the present invention.

FIG. 5A is a perspective view of a flush adapter for use with theforceps and collection assembly of FIG. 1 according an embodiment of thepresent invention.

FIG. 5B is a schematic cross-sectional view of the flush adapter of FIG.5A.

FIG. 6A is a schematic cross-sectional view of a forceps and collectionassembly and a removal mechanism according to another embodiment of thepresent invention.

FIG. 6B is a bottom perspective of the removal mechanism of FIG. 6A.

FIG. 6C is a top perspective view of the removal mechanism of FIG. 6A.

FIG. 6D is a side view of the removal mechanism of FIG. 6A.

FIG. 7A is a side view of a forceps and collection assembly according toanother embodiment of the present invention.

FIG. 7B is a front view of the forceps and collection assembly of FIG.7A.

FIG. 7C is a bottom view of the forceps and collection assembly of FIG.7A in a closed configuration.

FIG. 7D is a bottom view of the forceps and collection assembly of FIG.7A in an open configuration.

FIG. 8A is a perspective view of a removal mechanism according to yetanother embodiment of the present invention.

FIG. 8B is a side view of the removal mechanism of FIG. 8A.

FIG. 8C is a bottom view of the removal mechanism of FIG. 8A.

FIG. 8D is a side front view of the removal mechanism of FIG. 8B.

FIG. 9A is a perspective view of the forceps and collection assembly ofFIG. 1 being used in conjunction with a flush adapter according to stillanother embodiment of the present invention.

FIG. 9B is a perspective view of the forceps and collection assembly ofFIG. 1 being used in conjunction with a flush adapter according to afurther embodiment of the present invention.

FIG. 10A is a side view of the forceps and collection assembly of FIG. 1being used in conjunction with a portion of a flush adapter according toa still further embodiment of the present invention.

FIG. 10B is a side view of another portion of the flush adapter of FIG.10A.

FIG. 10C is a side view of a syringe for use with the flusher flushadapter of FIGS. 10A and 10B.

DESCRIPTION OF THE EMBODIMENTS

Reference will now be made in detail to the present exemplaryembodiments of the invention illustrated in the accompanying drawings.Wherever possible, the same reference numbers will be used throughoutthe drawings to refer to the same or like parts.

In the various embodiments, the invention relates to a forceps andcollection assembly for obtaining and storing multiple tissue samples.The invention also related relates to various mechanisms to work incombination with such a forceps. For example, embodiments of theinvention include an endoscope working channel cap configured to aid ininsertion and removal of the forceps and collection assembly andminimize compression of the collection assembly and its stored samples,to maintain the integrity of those samples. Another mechanism for use incombination with the forceps and collection assembly includes a flushadapter configured to assist in the removal of the biopsy samples fromthe collection assembly.

In embodiments that use the forceps and collection assembly in anendoscopic medical procedure, the forceps and collection assembly can beadvanced through a working channel cap that has a seal specificallydesigned for use with the forceps and collection assembly, down theworking channel of an endoscope, and into a tissue tract. When proximateto the tissue sites, the forceps and collection assembly can take andstore multiple biopsy samples, and then be retracted from the tissuetract through the working channel of the endoscope through the cap withthe seal specifically designed to assist in both keeping the biopsysamples in the collection assembly, for example a pouch, and maintainingthe diagnostic integrity of the biopsy samples. Once the forceps andcollection assembly has been retracted from the body, the collectionassembly is placed on a flush adapter configured to assist inefficiently removing the biopsy samples from the collection assemblywithout damaging the samples.

An embodiment of a forceps and collection assembly is depicted inFIG. 1. The forceps and collection assembly 10 includes an elongatetubular member 12 that is connected to an endoscopic actuator assembly 9(i.e. a handle portion) at the proximal end of the assembly 10 and anend effector assembly 11 at a distal end of assembly 10. The endoscopicactuator assembly 9 is shown schematically in FIG. 1 as simply a box, asassembly 9 may be any suitable handle known in the art that controls theactuation of the distal jaw assembly and/or forceps. Tubular member 12includes a flexible helical coil 13 that may include a covering. Anyalternative elongate member having sufficient flexibility to traversetortuous anatomy may be used to connect the proximal actuator assembly 9to the distal end effector assembly 11.

The main components of end effector assembly 11 include a clevis 17,jaws 15, and a collection assembly in the form of a pouch 16. At itsdistal end 18, tubular member 12 is connected to jaws 15 and pouch 16via clevis 17. The distal end of clevis 17 has a generally U-shapedconfiguration with a pivot pin 19 running between pivot holes 20 onopposing pivot arms 21 of the clevis 17. The center of the clevis 17 ishollow and configured to receive pull wires 14 used to actuate the jaws15 located between the pivot arms 21 of the clevis 17. The pull wires 14connect to jaws 15 and extend through clevis 17 and elongate member 12to the proximal actuation handle 9.

An embodiment of jaws 15 is depicted in FIGS. 2A-2B. The jaws 15includes an upper jaw 30 and a lower jaw 50. The upper jaw 30 and lowerjaw 50 each have pivot bores 31, 51 on the central part of theirrespective tang portions 32, 52 that are configured to accommodate thepivot pin 19 of the clevis 17 such that the upper jaw 30 and lower jaw50 can rotate about the pivot pin 19 with respect to each other. Boththe upper jaw 30 and lower jaw 50 have tang portions 32, 52 with pullwire holes 33, 53 on their proximal ends configured to receive andretain actuating pull wires 14 from the proximal actuation handle 9.Both the upper jaw 30 and lower jaw 50 also have central bridgingportions 34, 54 that connect their respective proximal tang portions 32,52 to distal cutting portions 35, 55. The upper jaw 30 and lower jaw 50are both made out of a biocompatible metal suitable for accommodatingand retaining sharp cutting edges 37, 57, or other material ofsufficient strength (e.g. plastic ceramic composite). The cuttingportions 35, 55 of the upper jaw 30 and lower jaw 50 are configured tobe opposable and match up with each other when brought together.

The cutting portion 35 of the upper jaw 30 includes a straight cuttingedge 37 around substantially the outer edge of the bottom part 36 of thecutting portion 35. Substantially adjacent to the inner portion of thestraight cutting edge 37 of the upper jaw 30 is an oval protrusion 38.The oval protrusion 38 is for pushing samples into the pouch 16connected to the lower jaw 50 once the tissue sample has been cut fromthe tissue tract. Substantially adjacent to the inner portion of theoval protrusion 38 on the bottom part 36 is a flat portion that hasventilating holes 39. The ventilating holes 39 are to assist inpreventing biopsy samples from being stuck on the bottom portion 36 ofthe cutting portion 35 by minimizing the surface area that samples maystick to the upper jaw 30.

The cutting portion 55 of the lower jaw 50 includes a straight cuttingedge 57 substantially around the outer edge of the top part 56 of thecutting portion 55. A sample receiving hole 58 is in the middle of thecutting portion 55 and is surrounded by a vertical wall 59 which has onits top part 56 the straight cutting edge 57. Along the bottom outeredge of the outside of vertical wall 59 is a groove portion 60. Thegroove portion 60 is configured to facilitate coupling of the pouch 16to the lower jaw 50, for example, by receiving and retaining aprotrusion on an upper part of the pouch 16.

An embodiment of pouch 16 is depicted in FIG. 3. Pouch 16 includes alower jaw interface portion 70, for example, on an inner protrusionalong its front rim 71 configured to be received and retained by thegroove portion 60 of the lower jaw 50. Extending away from the front rim71 is a base wall 72 defining a passage 73 in flow communication withthe sample receiving hole 58 of the lower jaw 50. Passage 73 isconfigured to receive biopsy samples from the jaws 15 through the samplereceiving hole 58. Alternative configurations may include holes in thelower jaw 50 to aid in pouch attachment such as insert molding the pouch16 directly to the jaw.

At the end of the base wall 72 opposite the front rim 71 is a pouchcontainer 74 with a central cavity 75. The cross-section of the pouchcontainer 74 is substantially cylindrical along its length. The centralcavity 75 is in flow communication and substantially axially alignedwith both the passage 73 and the sample receiving hole 58, and isconfigured to receive and retain the biopsy samples from the passage 73.The pouch container 74 has one or more ventilation holes 76 configuredto assist in preventing the biopsy samples from sticking to the innerwall 77 of the pouch container 74, such that the biopsy samples may bemore easily pushed into pouch 16 as samples are collected and removedfrom pouch 16 after assembly 10 is removed from a body. The ventilationholes 76 are configured to prevent such sticking by minimizing thesurface area contact between the tissue samples and inner wall 77. Theventilation holes 76 are also configured to allow fluid, for examplefrom the tissue samples, to escape from the forceps and collection pouchassembly 10.

At the bottom end of the pouch container 74 opposite the base wall 72 isa flush adapter interface 79 configured to be coupled with a flushadapter 110, to be described below. The flush adapter interface 79 has aroughly hourglass shape that defines a flush passage 78 that is open atits bottom. The flush adapter interface 79 with the flush passage 78 hasa restriction that is a narrowed portion of the pouch 16. Passage 78 isconfigured to facilitate flow communication between the central cavity75 of the pouch container 74 and the external environment, but preventbiopsy samples from exiting the pouch 16 through the bottom of the flushpassage 78, for example, because it has a smaller cross section than thetarget sample sizes. The flush passage 78 and the central cavity 75 aresubstantially axially aligned with each other. Pouch 16 may be made of aplastic or any other suitable biocompatible material.

An embodiment of an endoscope working channel cap assembly 90 isdepicted in FIG. 4. The cap assembly 90 includes a cap portion 91, a lidportion 92, and an introducer portion 96. The lid 92 protects theproximal end 93 of the cap 91 and is removed once the cap 91 is placedon the working channel of an endoscope and a medical instrument, forexample the forceps and collection assembly 10, is advanced through thecap 91. However, in other embodiments, the lid 92 may have a centralhole therethrough configured to accommodate the forceps and collectionassembly 10, and thus may be left on the proximal end 93 of the cap 91and act as a second seal. The lid 92 has a cap interface portion whichincludes resilient protrusions 106 with thick distal end portions 107that bend outward. The thick distal end portions 107 of the protrusions106 are configured to be placed in a groove 109 of a lid interfaceportion 108 of the cap 91 such that the lid 92 is held and retained onthe cap 91 until removal by the user.

On the distal end 94 of the cap 91 is an introducer interface 95configured to be connected to introducer 96. More specifically,interface 95 has a flange 100 and an internal groove 101 configured toreceive a port fitting 105 on the proximal end of the endoscope. Portfitting 105 has a cap interface portion 102 with a central groove 103and a proximal protrusion 104. The port fitting 105 is configured toreceive introducer 96, which has a hollow upper central shaft 98connected to a hollow lower central shaft 97 extending distally from cap91. The central groove 103 is configured to mate with the flange 100,while the proximal protrusion 104 is configured to mate with theinternal groove 101. The lower central shaft 97 of the introducer 96 isconfigured to extend through and open a seal of an existing cap on theendoscope working channel and is also configured to allow the forcepsand collection assembly 10 to be advanced and retracted through it, forexample, by having a diameter sufficient to allow passage of the forcepsand collection assembly 10.

The cap 91 itself accommodates the upper central shaft 98 of theintroducer 96 configured to allow the forceps and collection assembly 10to be advanced and retracted through it. The upper central shaft 98 isin flow communication with the lower central shaft 97 of the introducer96. Above the upper central shaft 98 of the introducer 96, cap 91includes a seal 99 configured to allow the forceps and collectionassembly 10 to be advanced and retracted through the cap 91 via the seal99. For example, the seal 99 may be a sheet with an X-shaped slit in themiddle that is normally closed, but opens up when the forceps andcollection assembly 10 extends therethrough. The seal 99 may be made ofrubber or plastic and may be integrally formed with the rest of cap 91.The seal 99 is configured to substantially separate the sterile internaltissue tract environment from the non-sterile external environment bothwhen closed and when the forceps and collection assembly 10 has beenadvanced through seal 99 and into the endoscope and tissue tract. In thelatter situation, the seal 99 interacts with the outer portion of thetubular member 12 connected to the forceps and collection assembly 10 toeffect the seal.

The seal 99 in this embodiment is different from the standard seal on astandard working channel cap known in the art, however, in that thestandard seal is configured such that when the forceps and pouchassembly 10 is retracted through the seal, pouch 16 may be compressedand the biopsy samples may either fall out of pouch 16 or they may becompressed and their diagnostic integrity compromised. This may be dueto the stiffness of the material comprising the standard seal and/or thegeometric configuration of the standard seal.

Accordingly, seal 99 in this embodiment is configured such that thepouch 16 is not compressed to the extent in a standard seal, such thatthe biopsy samples are both retained in the pouch 16 while, traversingthe seal 99 and their diagnostic integrity is preserved. Such alessening in compression may be obtained, for example, by making theseal 99 out of a softer or more pliable material, or by geometricallyconfiguring the seal 99 such that less pressure is applied to the pouch16 while it traverses the seal 99. For example, the seal 99 may beangled, may have additional central slits, or may have slits longer thanthe standard seal.

FIG. 5 depicts an embodiment of a flush adapter 110. The flush adapter110 is configured for use with the forceps and collection assembly 10depicted in FIGS. 1-3. The main portion of the flush adapter 110 is acylindrical shroud 111 with a central cavity 112 that is configured tobe watertight and hold the pouch 16. Accordingly, the cross-sectionalarea of the cylindrical shroud 111 is larger than the cross-sectionalarea of the pouch container 74, and may have substantially the samecross-sectional shape as the pouch container 74. The inner walls 113 ofthe cylindrical shroud 111 may be configured to withstand fluid pressurefrom the ventilation holes 76 when the pouch container 74 is placed inthe cylindrical shroud 111. For example, the inner walls 113 may bedimensioned so that there is either no gap or only a very small gapbetween the outer surface of the pouch container 74 and the inner wall113 of the cylindrical shroud 111. Thus, even if fluid pressure were tobuild in the ventilation holes 76 and place pressure on the inner wall113 of the cylindrical shroud 111, no fluid or only minimal fluid wouldflow between the outer surface of the pouch container 74 and the innerwall 113 of the cylindrical shroud 111.

One open end of the cylindrical shroud 111 flares out into a jaw stop114 with notches 115 on opposites side of the jaw stop 114. That endaccepts pouch 16. The flared shape of jaw stop 114 aids in guiding thepouch 16 into the cylindrical shroud 111 of the flush adapter 110, andthe notches 115 are configured to receive portions of the lower jaw 50.The notches 115 also tactically indicate alignment of the forceps andpouch assembly 10 with the flush nozzle 121. For example, when portionsof the lower jaw 50 are fitted into the notches 115, that indicates thatthe flush adapter interface 79 is aligned with and formed asubstantially watertight connection with flush nozzle 121.

On the other end of the cylindrical shroud 111 of the flush adapter 110opposite the jaw stop 114 is a luer lock 116. The luer lock 116 may beconfigured to fit conventional syringes. Luer lock 116 includes a funnelshaped central shaft 117 and a locking portion 118 configured to mate toa syringe or any other device capable of delivering fluid. Lockingportion 118 essentially comprises an outer flange at the end of lock116.

Between the luer lock 116 and the cylindrical shroud 111 is a supportportion 119. The support portion 119 has a larger cross-sectional areathan either the cylindrical shroud 111 or the luer lock 116, and isconfigured to, among other things, provide structural support for theflush adapter 110 and allow a user to hold the flush adapter 110.Portion 119, cylindrical shroud 111, and luer lock 116 may be formed asan integral unit.

In the central portion of the support portion 119 is a hollow shaft 120terminating in a flush nozzle 121. Shaft 120 may be a hypotube, part ofwhich is lodged in the support portion 119, and part of which extendsinto the central cavity 112 of the cylindrical shroud 111. Hypotube 120is configured to allow flow communication between the central shaft 117of the luer lock 116 and the central cavity 112 of the cylindricalshroud 111. Hypotube 120 is configured to be mated with the flushadapter interface 79 of the pouch 16. The hypotube 120 is configured tobe placed inside the flush passage 78 of the flush adapter interface 79.The passage 78 and hypotube 120 may be dimensioned so as to form asubstantially watertight seal therebetween and/or allow fluidcommunication between the central shaft 117 of the luer lock 116 and thecentral cavity 75 of the pouch container 74.

In other embodiments, the forceps and collection assembly 10 may havevarious alternate configurations. For example, the clevis 17 may be anyconnector piece configured to couple the distal end effector assembly 11to tubular member 12. In addition, instead of pull wires 14, assembly 10may include any components suitable for connection to and actuation ofjaws 15 or any other distal end effector assembly. Accordingly, theupper jaw 30 and lower jaw 50 need not have pull wire holes, but insteadmay have components configured to interface with any actuation assemblyknown in the art. The cutting portions 35, 55 of the upper and lowerjaws 30, 50 need not be straight edge, but may have serrations, teeth,or any other cutting configuration that can cut tissue portions whenbrought together.

In other embodiments, pouch 16 may have various alternateconfigurations. For example, pouch 16 may have other shapes and may becomposed of any suitable biocompatible material. The pouch 16 may becomposed of a material and/or have a wall thickness that allows adesired amount of flexibility and/or compression of the pouch 16 as ittraverses the seal on the cap assembly 90. For example, if the biopsysamples are especially sensitive, the pouch 16 may be configured to bemore rigid such that it does not bend or compress as much when it comesinto contact with either a tissue tract wall or the seal 99 on the capassembly 90. The flush adapter interface 79 need not have an hourglassshape, as any configuration that can be coupled to the flush adapter 110while also preventing biopsy samples from exiting the central cavity 75through the flush adapter interface 79 is also contemplated. Inaddition, the pouch 16 may be integrally formed with the lower jaw 50 sothat they form one piece.

In other embodiments, the cap assembly 90 may have various alternateconfigurations. For example, the seal 99 need not be made of rubber orplastic or integrally formed with the cap 91. Seal 99 may be separatelyformed and then added to the rest of cap 91, and the seal 99 may be madeof any material and mechanism known in the art for separating a sterileenvironment from a non-sterile environment (e.g. a membrane).

In other embodiments, the flush adapter 110 may have various alternateconfigurations. For example, the luer lock 116 may be configured toreceive the interface of any style syringe or other fluid deliverydevice. The jaw stop 114 need not be flared out, as it may have anyconfiguration that assists in guiding the pouch container 74 into thecylindrical shroud 111. The jaw stop 114 need not have a notch 115, asthe pouch 16 may be completely disassembled from the lower jaw 50 beforebeing placed in the flush adapter 110. The hypotube 120 may beconfigured to receive a needle of a syringe, thus fluid may flow fromthe syringe through the needle, into the hypotube 120, out the flushnozzle 121, and into the central cavity 75 of the pouch container 74. Inaddition the flush adapter 110 may be configured without hypotube 120and support portion 119, instead aligning the syringe and forceps andpouch assembly 10 so that the syringe is in direct fluid communicationwith the flush hole 78 of the flush adapter interface 79.

In other embodiments, the forceps and collection assembly 10 and theaccompanying mechanisms described above may be used with any medical ornon-medical procedure. In addition, each of the forceps and collectionassembly 10, cap assembly 90, and flush adapter 110 may be usedindependently of the other two, each being individually configured to beused with other similar but not necessarily identical parts. Forexample, the cap assembly 90 may be used with any endoscopic medicalinstrument that may require a more sensitive and/or pliable seal 99. Inanother example, the flush adapter 110 may be used with any device orcontainer that may require a coupling in order to run fluid from a fluidsource to the device or container.

A method of using the forceps and collection assembly 10 andaccompanying mechanisms will now be described. Once an endoscope with aworking channel has been provided, the cap assembly 90 is placed on theproximal end of the working channel, typically over an existing workingchannel cap. Specifically, the central shaft 97 of the introducer 96 isinserted into the standard cap already on the working channel such thatthe central shaft 97 traverses the seal of the standard cap. Eitherbefore or after placement of cap assembly, the endoscope is placed intothe body, for example, a tissue tract, using a method known in the artand the entire procedure may be viewed using any suitable method knownin the art.

Once the endoscope has been placed in the desired body portion and/ortissue tract, lid 92 may be removed (although it need not be removed ifit has a through hole) and a forceps and collection pouch assembly 10 isinserted through cap assembly 90, and specifically through central shaft98 of cap 91 and shaft 97 of introducer 96, and into the working channelof the endoscope to the endoscope distal end. During insertion, theupper jaw 30 and lower jaw 50 are closed. The distal end effectorassembly 11 is then advanced to the desirable tissue portion or portionsand actuated. Specifically, once the jaws 15 are positioned proximatethe tissue portion from which a sample is desired, the user actuates ahandle portion and the jaws 15 are opened (i.e. the upper jaw 30 andlower jaw 50 are separated). For example, the pull wires 14 are advanceddistally and push on the pull wire holes 33, 53 on the tang portions 32,52. The pushing causes the tang portions 32, 53 of the upper jaw 30 andlower jaw 50 to rotate away from each other and thus cause the jaws 15to open. The pull wires 14 may be advanced distally using any methodknown in the art, for example, by pushing on a spool portion of ahandle.

Once jaws 30, 50 are open, the forceps and collection assembly 10 isadvanced to the desired tissue and the jaws 30, 50 are closed. Forexample, the pull wires 14 are retracted proximally, pulling on the pullwire holes 33, 53 of the tang portions 32, 52. The pulling causes thetang portions 32, 52 to rotate toward each other and the jaws 15 toclose. While the jaws 15 close, a sample of tissue is caught between theupper jaw 30 and lower jaw 50 of the jaws 15. The cutting portions 35,55 of the upper jaw 30 and lower jaw 50 then interact and cause a biopsysample to be cut from the tissue tract. As the jaws 15 close, the ovalprotrusion 38 pushes the biopsy sample into the central hole 58 of thelower jaw 50 and into the passage 73 past the front rim 71 of the pouch16, and into the central cavity 75 of the pouch container 74. Thecentral hole 58, the passage 73, the central cavity 75, and passage 78and its open bottom are substantially axially aligned with each other.

Once in the central cavity 75 of the pouch container 74, the biopsysamples should fall toward the flush adapter interface end 79 of thepouch 16. However, even if they initially do not, acquisition of furthersamples by the jaws 15 should push the biopsy samples already in thecentral cavity 75 further from the front rim 71 and base wall 72. Toprevent biopsy samples from getting stuck in the central cavity 75 andimpeding the acquisition of further biopsy samples, the ventilationholes 76 assist in preventing such sticking by reducing the surface areaon which the tissue samples can stick, thus facilitating the movement ofthe biopsy samples toward the flush adapter interface end 79. As theflush hole 78 is adapted to be too narrow for biopsy samples cut by thejaws 15 to pass, the biopsy samples are stored in the pouch container 74between the flush adapter interface 79 and the front rim 71 untilremoval. The flush hole 78 is substantially axially aligned with thecentral cavity 75 of the pouch container 74.

Once the biopsy sample is stored in pouch 16, the distal end effectorassembly 11 may be advanced to additional tissue tract portions where abiopsy sample may be desired, and the biopsy samples may be taken usingthe method substantially as set forth above. These steps may be repeatedas many times as desired until either the user decides to ceaseacquisition of further biopsy samples or the central cavity 75 of thepouch container 74 reaches its maximum capacity.

Once the user decides that enough biopsy samples have been acquiredduring a single pass, assembly 10 is retracted out of the tissue tractand the working channel of the endoscope. Specifically, with jaws 15 ina closed position, forceps and collection assembly 10 is retracted backout of the endoscope working channel and cap assembly 91. During thisprocedure, because the seal 99 is configured to more lightly compressthe pouch 16 as it traverses the seal 99 (at least as compared to a sealon a standard working channel cap), there is less risk that pouch 16will be compressed such that either the biopsy samples are pushed out ofthe pouch 16 or the samples are compressed so as to compromise thediagnostic integrity of the samples.

Once the assembly 10 is retracted out of the endoscope, the biopsysamples are removed from the pouch 16. Specifically, the lower jaw 50and pouch 16 are placed in the central cavity 112 of the cylindricalshroud 111 of the flush adapter 110 being guided by the jaw stop 114.The pouch 16 is placed almost completely in the central cavity 112 ofthe cylindrical shroud 111. The flush adapter interface 79 receivesflush nozzle 121 such that the flush nozzle 121 is placed in the flushpassage 78 of the flush adapter interface 79. The flush nozzle 121 maybe lodged sufficiently in the flush passage 78 such that a substantiallywatertight seal is formed, and the hollow central shaft of hypotube 120is in fluid communication with the flush passage 78. Notches 115 assistin this alignment process by tactically indicating when the jaw 50 isseated. Thus, the result is that the hypotube 120, the flush passage 78,the central cavity 75, and the passage 73 are all substantially axiallyaligned with each other.

Either prior to or subsequent to placing the pouch 16 in the flushadapter 110, the Iuer lock 116 is coupled to a syringe. Specifically,the locking portion 118 of the luer lock 116 is locked with a matingportion of the syringe such that a substantially watertight seal isformed between the syringe and the luer lock 116. Accordingly, when thepouch 16, flush adapter 110, and syringe have been properly coupledtogether, the syringe and central cavity 75 of the pouch 16 are insubstantially watertight fluid communication via the central shaft 117of the luer lock 116 and the hypotube 120.

Accordingly, once the pouch 16 has been placed in and coupled to theflush adapter 110, and the syringe has been coupled to the flush adapter110, fluid is advanced out of the syringe and into the central shaft 117of the luer lock 116. The fluid may be a sample preservation fluid, asaline solution, or any other type of desired fluid. From the syringe,the fluid flows through hypotube 120 and past flush nozzle 121 and intothe central cavity 75 of the pouch container 74. In the central cavity75 of the pouch container 74, the fluid will come into contact with thebiopsy samples. The fluid then pushes the biopsy samples to the centralpassage 73 of the base wall 72 and then through the front rim 71. Fromthere, the biopsy samples will be taken away for analysis or any othertype of desired procedure. The endoscope may be withdrawn from the bodybefore or after removal of samples from pouch 16.

In the various embodiments, any suitable method of viewing the procedureis contemplated, for example, the use of the endoscope lens orelectronic methods of viewing endoscopic procedures that are known inthe art.

In other embodiments, there may be various alternate method steps thatmay be executed. For example, there may not be a standard cap already onthe end of the working channel of the endoscope, and the cap assembly 90may not need an introducer 96 at all or in the form described above.Accordingly, a cap assembly 90 without an introducer may be mated withthe working channel of the endoscope via the working channel interface95 of the cap 91. As a further alternative, the upper and lower jaws 30,50 may be individually actuated (i.e. only one jaw moves to open andclose the jaws 15) and/or one jaw may be stationary and the othermovable.

FIG. 6A depicts an alternate embodiment of a forceps and collectionassembly 130. While the forceps and collection assembly 130 has upperand lower jaws with a pouch for storing multiple samples coupled to thelower jaw, there may be several differences from the embodiment depictedin FIGS. 1-3. For example, in this embodiment of forceps and collectionassembly 130, the upper and lower jaw portions may be actuable about theclevis so that the upper jaw may be positioned at substantially a 90degree angle with respect to the tubular member, while the lower may besubstantially parallel to the tubular member such that the pouch ispositioned at substantially a 90 degree angle with respect to thetubular member.

In another example, the bottom of the pouch may have a removal holeconfigured to prevent tissue samples from exiting the pouch via theremoval hole without assistance, but allowing tissue samples to exit thepouch via the removal hole with assistance. Such a configuration can beattained, for example, by roughly determining the size of tissue samplesthat would be cut by the forceps jaws, and then sizing the hole to besmaller than the determined sample size, or by using a pouch like thatshown in FIGS. 7A-7D.

FIGS. 7A-7D depict another alternate embodiment of the forceps andcollection assembly 150. While the forceps and collection assembly 150has upper and lower jaws with a pouch for storing multiple samplescoupled to the lower jaw, there may be several differences fromembodiments depicted in FIGS. 1-3 and FIG. 6A. For example, the pouch ofassembly 150 may have an openable and resealable bottom 151. As depictedin FIGS. 7A-7C, the pouch 152, when closed, may have a wedged shapedconfiguration with the bottom portion 151 having a sealing mechanism.When the bottom portion is opened, it may have a roughly circularconfiguration as depicted in FIG. 7D. The sealing mechanism may be anumber of slits in bottom portion 151 that, due to the resilientmaterial of pouch 152, are normally mating so that bottom 151 remainsclosed. When the bottom 151 is closed, the sealing mechanism may preventtissue samples from exiting through the opening without assistance, butwhen either the user opens the bottom or enough external downwardpressure is applied to the tissue samples, the tissue samples may bepushed or simply fall out of the pouch through the bottom opening.

FIGS. 6A-6D also depict an exemplary embodiment of a removal mechanism131 for use, for example, with the forceps and collection assemblydepicted in either FIG. 6A or FIGS. 7A-7D. The removal mechanism 131 hasa cylindrical main body 132 partially open on the proximal end 133 andthe bottom portion 134, and closed on the distal end 135. On the top ofremoval mechanism 131 is a thumb-activated plunging mechanism 136hingeably coupled on a proximal end of an activation portion 137 to themain body 132. The activation portion 137 extends distally from thehinged portion until it roughly reaches the location of a plunger hole138 on the main body 132. At the location of the plunger hole 138, theactivation portion 137 is coupled to a plunger 139. The plunger 139traverses the plunger hole 138 and has a return spring 140 disposedaround it on the portion of the plunger 139 between the activationportion 137 and the main body 132.

The main body 132 has an insertion slot 141, as depicted in FIGS. 6B and6D, configured to accommodate the forceps and collection assembly, forexample, depicted in FIG. 6A or FIGS. 7A-7D. The insertion slot 141 hasa circular portion 142 in substantially the central part of the proximalend 133 of the main body 132, with the rest of the slot 141 extendingaway from the circular portion 142 until it reaches the bottom 134 ofthe main body 132. On the bottom 134 of the main body 132, the insertionslot 141 extends distally away from the proximal end 133, and endsroughly at the portion of the main body 132 opposite the plunger hole138.

An embodiment of the interior of the main body 132 is depicted in FIG.6A. Moving distally from the circular portion 142 of the insertion slot141, the insertion slot 141 flares out into a cavity 143 which endssubstantially between the plunger hole 138 and the distal end of theinsertion slot 141. In the portion of the cavity 143 adjacent theplunger hole 138, there is a wall portion 144 that extends down and isconfigured to contact a portion of the upper jaw.

Accordingly, the forceps and collection assembly is placed in andaligned with the removal mechanism 131 such that the upper jaw contactsthe wall portion 144 adjacent the plunger hole 138, and the pouch is inthe insertion slot 141 with its opening directly beneath the plungerhole 138. The user then depresses the activation portion 137 such thatthe plunger 139 goes into the top opening of the pouch and pushes thetissue samples in the pouch out the removal hole of the pouch of FIG. 6Aor the opening 151 of the pouch of FIGS. 7A-7D. The return spring 140then returns the activation portion 137 to its original position.

FIGS. 8A-8D depict another exemplary embodiment of a removal mechanism160 for use, for example, with the forceps and collection assemblydepicted in either FIG. 6A or FIGS. 7A-7D. The removal mechanism 160 hasa main block 161 attached at one end 162 above the open end of a fluidcontainer 163 as depicted in FIG. 8B, and having on the other end 164 aninsertion opening 165 as depicted in FIGS. 8A and 8D. The insertionopening 165 and its accompanying insertion slot 166 has a wide middleportion 167, narrower top portion 168, and narrow bottom portion 169that run substantially the entire length of the main block 161. Thewidth of the top 168 and middle portions 167 are substantially constantalong their entire length, while the width of the bottom portion 169narrows toward the attachment end 162, as shown in FIGS. 8C and 8D. Thewide middle portion 167 is configured to receive the forceps of theforceps and collection assembly, the top portion 168 is configured toallow the traversal of the tubular member of the forceps catheter, andthe bottom portion 169 is configured to accept and squeeze the pouch tofacilitate the removal of the tissue samples into the fluid container.

Accordingly, in an exemplary method of using the mechanisms depicted inFIGS. 8A-8D, closed forceps jaws of a forceps and collection assemblyare placed in the wide middle portion 167 of the insertion slot 165 withthe tubular member extending through portion 168 and the pouch extendingthrough portion 169 until the pouch is squeezed at its top. The userthen pulls upward on the tubular member causing the forceps jaws andpouch to be pull pulled upward and the pouch to be squeezed between thenarrowing bottom portions 169 of the insertion slot 165. This squeezingcauses the tissue samples to fall out of the bottom of the pouch andinto the fluid container 163.

FIGS. 9A and 9B depict alternate embodiments of a flush adapter beingused in conjunction with the forceps and collection assembly of FIGS.1-3. FIG. 9A shows a flush adapter having a housing portion 182 with aninternal nozzle 181 and a pouch cavity 185. A syringe 180, with aplunger 183, is placed in fluid communication with nozzle 181, which issubstantially cone shaped, and cavity 185. Cavity 185 is configured toreceive a pouch of a forceps and collection assembly, for example, ofFIGS. 1-3. Housing 182 also includes a male luer lock 184 to be receivedby a female luer lock of the syringe. Fluid flows from the syringe 180,through the nozzle 181, and into the pouch placed in cavity 185.

In another example, the flush adapter of FIG. 9B is similar to theembodiment of FIG. 9A in that it has a housing portion 192 with a nozzle191 and a male luer lock 194. In this embodiment, nozzle 191 has aparabolic taper.

FIGS. 10A-10C depict another alternate embodiment of a flush adapterthat may be used in conjunction with the forceps and collection assemblyof FIGS. 1-3. The flush adapter is similar to the flush adapters ofFIGS. 9A and 9B, but differs in certain aspects. In this embodiment, asyringe 200 is coupled to an intermediate portion 205 through a luerconnection. The syringe 200 has a male luer lock 207 configured to becoupled and in fluid communication with the female luer lock 208 of theintermediate portion 205. The intermediate portion 205 has a hypotube201 with a nozzle on one end and a housing mating portion 204 configuredto mate with a mating portion 203 of a housing portion 206. The syringe200 also has a housing mating portion 209 configured to be coupled tothe mating portion 203 of the housing portion 206. The mating portion203 is screwed onto a pouch accommodating portion 202 configured toreceive the forceps and collection assembly, for example, of FIGS. 1-3.Accordingly, fluid from the syringe 200 is run through the hypotube 201of the intermediate flushing device 205, out the nozzle portion, andinto the pouch 210 which is lodged in the pouch accommodating portion202 of the housing portion 206.

Other embodiments of the invention will be apparent to those skilled inthe art from consideration of the specification and practice of theinvention disclosed herein. It is intended that the specification andexamples be considered as exemplary only, with a true scope and spiritof the invention being indicated by the following claims.

1. A method of acquiring a plurality of tissue samples comprising: usinga cutting device to cut a first tissue sample from an internal tissuetract of a patient; storing the first tissue sample in a containercoupled to the cutting device, wherein the cutting device is disposedwithin the internal tissue tract; without removing the cutting devicefrom the patient, using the device to cut a second tissue sample fromthe internal tissue tract; storing the second tissue sample in thecontainer disposed within the internal tissue tract; wherein thecontainer has a cavity for storing the first and second tissue samples,an open top, and an open bottom substantially axially aligned with andin flow communication with the open top; and wherein a portion of thecontainer adjacent the open bottom has a restriction smaller than theopen bottom to prevent the first and second tissue samples from exitingthe container via the open bottom; removing the cutting device from theinternal tissue tract of the patient; and coupling a fluid deliverydevice to the container such that the open bottom of the container andthe open top of the container are received in the fluid delivery deviceto flush the first and second tissue samples from the container.
 2. Themethod of claim 1, further comprising pushing each of the first andsecond tissue samples into the container.
 3. The method of claim 1,wherein the cutting and pushing occur substantially simultaneously. 4.The method of claim 1, further comprising traversing a seal of anendoscope working channel with an introducer portion of a cap assemblyto keep open the seal, wherein the introducer portion is configured toaccommodate the cutting device.
 5. The method of claim 4, wherein thecap assembly includes a seal.
 6. The method of claim 4, furthercomprising traversing a seal of the cap assembly with the container andthe first and second tissue samples stored in the container.
 7. Themethod of claim 6, wherein the step of traversing the seal of the capassembly occurs without the seal of the cap assembly forcing either ofthe first and second tissue samples out of the container.
 8. The methodof claim 6, wherein the step of traversing the seal of the cap assemblyoccurs without the seal of the cap assembly compromising the diagnosticintegrity of either of the first and second tissue samples.
 9. Themethod of claim 1, further comprising delivering fluid through the openbottom to flush the tissue samples out of the cavity via the open top.10. The method of claim 9, wherein the step of delivering fluid includesdelivering fluid from the fluid delivery device to the open top via theopen bottom and the cavity.
 11. The method of claim 1, wherein the fluiddelivery device includes a source of fluid and a flushing device tocouple the source of fluid to the container.
 12. The method of claim 11,further comprising extending a nozzle of the flushing device into theopen bottom of the container.
 13. A method of acquiring a plurality oftissue samples comprising: using a device to obtain a first tissuesample from an internal tissue tract of a patient; storing the firsttissue sample in a container coupled to the device, wherein thecontainer is disposed within the internal tissue tract; without removingthe device from the patient, using the device to obtain a second tissuesample from the internal tissue tract; storing the second tissue samplein the container disposed within the internal tissue tract; wherein thecontainer has a cavity for storing the first and second tissue samples,an open top, and an open bottom in flow communication with the open top;and wherein a portion of the container adjacent the open bottom has arestriction smaller than the open bottom; removing the device from theinternal tissue tract of the patient; and inserting the container into aflushing device such that the open bottom of the container and the opentop of the container are received in the flushing device to flush thefirst and second tissue samples from the container.
 14. The method ofclaim 13, further comprising extending a nozzle of the flushing deviceinto the open bottom of the container.
 15. The method of claim 14,wherein the portion of the container adjacent the open bottom isconfigured to form a substantially fluid tight coupling with the nozzle.16. The method of claim 15, further comprising delivering fluid throughthe nozzle to flush the tissue samples out of the cavity via the opentop.
 17. A method of acquiring a plurality of tissue samples comprising:using a first device to obtain a first tissue sample from an internaltissue tract of a patient; storing the first tissue sample in acontainer coupled to the first device, wherein the first device isdisposed within the internal tissue tract; without removing the firstdevice from the patient, using the first device to obtain a secondtissue sample from the internal tissue tract; storing the second tissuesample in the container disposed within the internal tissue tract;wherein the container has a cavity for storing the first and secondtissue samples, an open top, and an open bottom in flow communicationwith the open top; and wherein a portion of the container adjacent theopen bottom has an hour-glass shape; removing the first device from theinternal tissue tract of the patient; and matingly engaging a seconddevice with the portion of the container adjacent the open bottom toremove the first and the second tissue samples from the container,wherein the open top of the container is received in the second devicewhen the second device is engaged with the portion of the containeradjacent the open bottom of the container.
 18. The method of claim 17,wherein the second device includes a source of fluid and a flushingdevice to couple the source of fluid to the container.
 19. The method ofclaim 18, wherein the flushing device comprises: an elongate memberdefining a receiving cavity, an open top, and an open bottom; aconnector at the open bottom of the elongate member, wherein theconnector is configured to provide a fluid tight connection with thesource of fluid; and a nozzle within the elongate member between theopen bottom of the elongate member and the receiving cavity, wherein thenozzle extends from the open bottom of the elongate member into andwithin the receiving cavity; and wherein the open bottom of the elongatemember is in flow communication with the open top of the elongate membervia the nozzle and the receiving cavity.
 20. The method of claim 19,further comprising extending the nozzle of the flushing device into theopen bottom of the container.